Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
Condition(s) studied
Investigational drug(s) / intervention(s)
HS-10380: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose
Aripiprazole: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose
Placebo: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose
Study summary
This is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability.
Eligibility
Primary outcome measure(s)
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42) — Baseline and Week 6
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality |
On this site
📄 Abilify (aripiprazole) drug profile →More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07911787 on ClinicalTrials.gov ↗ ← All trials in China